Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Device: Standard PS RP-MB (P.F.C Sigma Rotating Platform knee); Device: High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)

Study type: Interventional

Funder types: Other

Identifiers

NCT00954954

SNUHOSKNEE01-RPRPF

Details and patient eligibility

About

The aim of this prospective study is to compare the clinical and radiographic outcomes of standard and high-flexion posterior stabilized (PS) rotating-platform mobile-bearing (RP-MB) total knee arthroplasty. The investigators hypothesize that total knee arthroplasty performed with a high-flexion PS RP-MB design would improve range of motion, and that this would be reflected by a better clinical outcome and greater patient satisfaction.

Full description

A high-flexion, PS RP-MB prosthesis was designed to improve range of motion after total knee arthroplasty without compromising the theoretical advantages of the standard PS RP-MB system. To date, no study has prospectively compared the clinical and radiographic results of standard and high-flexion PS RP-MB designs.

Enrollment: 170 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A diagnosis of primary osteoarthritis of knee
• A candidate for total knee replacement arthroplasty

Exclusion criteria

• A diagnosis other than primary osteoarthritis
• A history of previous open knee surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

170 participants in 2 patient groups

Standard

Active Comparator group

Description:

Knees that will be implanted with standard posterior stabilized RP-MB knee prostheses

Treatment:

Device: Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)

High-flexion

Active Comparator group

Description:

Knees that will be implanted with high-flexion posterior stabilized RP-MB knee prostheses

Treatment:

Device: High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)